SOMERSET, N.J., Oct. 17 /PRNewswire/ -- Wave Biotech, LLC, has announced today that the company is working with a number of worldwide pharmaceutical and biotech manufacturers that are making vaccines in the disposable Wave Bioreactor(R). In its latest collaboration effort, Wave Biotech has entered into an agreement with Novavax, Inc. , based in Malvern, PA, and both companies will jointly collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Wave Biotech will provide process and equipment expertise for the propriety technology based on disposable equipment for the manufacture of biologicals. The initial focus of the collaboration will be on Novavax's H5N1 avian-flu-Like Particle (VLP) vaccine. The joint collaboration will demonstrate in a production process that can express potent vaccine at high yield at the 500-liter scale.

Vijay Singh, President and founder of Wave Biotech, LLC, issued the following statement: "Wave Biotech's disposable cell culture technology is an ideal fit for the Novavax application because it provides scalable technology that can be delivered, installed, and commissioned quickly for possible worldwide use."

Non Traditional Approach May Prove Necessary in the Race Against Time

Wave Biotech first began development on their innovative technology for the bioreactor six years ago, which may prove to be a critical component in the race to develop vaccines before a flu pandemic has an opportunity to occur. The company offers a quick way to rapidly manufacture and deploy bioreactors of up to 500 liters operating volume. Using large plastic bags as cell culture vessels, the bags are inflated, filled with culture nutrients, and inoculated with the cells of choice. These bags are placed on special machines that rock in a back and forth motion, generating waves that effectively aerate and mix the contents, thus producing a highly effective environment for cell growth and productivity. The machines have been fully operational since 1999, and are currently in use at almost every pharmaceutical or biotech company worldwide. They have been licensed as part of processes to produce human therapeutics and are built to comply with all applicable FDA guidelines. Most critically, they have a proven track record with many cell lines and viruses having been used for the production of proteins, viruses, gene therapy products, and vaccines. Due to the inexpensive and simple pre-sterilized disposable culture bag, cell culture can be carried out by low-tech labor without the need for extensive plant infrastructure. The rocking machines are mass-produced and can be delivered in weeks as compared to six months or longer for traditional stirred tank bioreactors.

Dr. Singh acknowledged that current issues concerning the possibility of an influenza pandemic striking humanity in the very near future is based on several notable factors. "First of all, the influenza virus is capable of mutating rapidly so that most people would have no significant resistance and would succumb. Additionally there is a disturbing increase in the occurrence of avian flu in Asia as well as the latest evidence in some of the eastern European countries. It is clear that the great influenza epidemic of 1918 was avian origin, followed by others in 1957 and 1968," he said. "Statistically," he continued, "another appears to be due at this time." He also noted that there are now anti-viral pharmaceuticals that may be useful in treating those people infected by the influenza virus, but he cautioned that the efficacy and availability of such drugs are very limited.

"The problem with influenza vaccines is that the virus mutates rapidly and a vaccine made against one strain will likely be useless against another one," said Singh. "Making such a vaccine is very time consuming and takes eight to ten months to build up a significant stockpile of doses."

The manufacturing equipment developed by Wave Biotech can be quickly configured and deployed anywhere in the world within days. The cells only contact a single-use bag and these bags can be stockpiled for up to three years providing an option for almost instant vaccine manufacturing. The equipment has been optimized over several years to enable easy operation with minimal training required. This method would enable vaccine facilities to be rapidly established anywhere in the world to combat the disease at the local level, thus preventing its release into the general population. The disposable cell culture bags can be manufactured in large quantities in simple factories using heat seaming equipment, delivered pre-sterilized by radiation and ready for use.

Engineered Baculovirus

Current vaccine manufacturers use 1950's chicken egg technology and other methods to make the vaccine. Singh considers these methods far more primitive because "even 350 million chicken eggs would only yield 300 million doses which would take at least six months to develop." Dr. Singh added, "This technology is not likely to save a significant number of people since compounding the problem is that if, indeed, the flu is avian origin, then where are the significantly large numbers of eggs needed to make the vaccine going to originate? The Spanish Flu epidemic of 1918 is estimated to have killed between 50 and 100 million people, at a time when world population was only 1.8 billion. Today we have 6.5 billion people and the impact of a virus such as the one in 1918 would clearly prove to be even more devastating."

Singh claims it is both necessary and critical for governments worldwide to secure alternative technologies to rapidly make an engineered cell line for vaccine production.

"One approach, developed by Novavax, is to identify the gene sequences of the virus as it exists now in the Far East and rapidly clone into baculovirus," said Dr. Singh. "This engineered baculovirus can be used to infect insect cells grown in liquid culture media and rapidly express large amounts of a suitable vaccine. This approach has been tested, proven and requires simple culture media that can be made from common chemicals. This way, it is possible to clone and develop a cell expressions system against a specific influenza strain within six weeks of securing the sample. While getting a cell line that produces the desired vaccine is only part of the story, in order to make sufficient quantities of the vaccine in such a time- sensitive manner, it will be essential to grow large numbers of cells using thousands of liters of cell culture capability."

About Wave Biotech

Wave Biotech is a research-based company that develops and manufactures innovative process equipment for the pharmaceutical and biotechnology industries. The Company's focus is on developing disposable bioprocess equipment for the operation traditionally requiring stainless-steel tanks and piping. Key products, such as the Wave Bioreactor(R), WaveMixer(R), FlexMixer(R), and Sterile Tube Fuser, feature disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging from cell culture, media preparation, and buffer dissolution and thawing process intermediates to patient specific cell therapy in hospitals. These unique, patented, devices can be installed and commissioned rapidly, thereby drastically reducing the time-to-market for biological products. Wave Biotech's equipment is in use with hundreds of companies worldwide, both for R&D, as well as commercial applications.